QS in the USA

Plans are underway to obtain US Food and Drug Administration (FDA) approval of clinical trials of QS.  Certain FDA required toxicology studies will be initiated because a foundation has finally provided resources to complete them.  The FDA could approve phase I or phase II trials concurrently with the toxicology studies, the first of which, on mouse neonates, will be completed by July 2001.  At present, it is not certain when a phase II trial will be initiated, or what its size might be.  In the meantime, it is expected that off-label use of QS will spread in the USA.  The pattern is similar to the case of Depo Provera, which was used for years as an off-label drug before FDA approval was given for contraception.

QS is provided in the USA by compound pharmacists who make up the quinacrine pellets and inserters on prescription of a doctor or a nurse practitioner (where they are permitted to prescribe).  This is based on an amendment to the Food and Drug Administration law, known as the Modernization Act, which became effective in November 1998.  All ingredients in the quinacrine pellets meet FDA standards as does the sterilization process of pellets and inserters.

A sample of pellets is tested for quality assurance before compound pharmacists fill such prescriptions.  We are informing clinicians about QS at their professional meetings.  However, the provision of QS in the USA is a matter between the patient, clinician and pharmacist.

China QS Trials Evaluated

The State Family Planning Commission of China has evaluated their QS clinical trials in Jiangsu Province and Guizhou Province.  Comparison was made between 572 QS acceptors to an equal number of women who elected surgical sterilization. No difference was found between the two groups in terms of blood chemistries, such as liver function or kidney function tests, or in gynecologic examinations.  Side effects such as headache, pelvic pain, vaginal infection, fever and lack of energy were significantly lower in the QS group.  QS was well accepted by women in the study.

QS Workshop at APHA Convention

My father, Dr. Clarence Gamble, an advisor to Margaret Sanger, founded Pathfinder Fund, now known as Pathfinder International, to help bring contraceptives to women around the world.  His battles and Margaret Sanger’s with birth control opponents remind me today of what we are facing with QS, a female non-surgical sterilization method already used by over 100,000 women with no reported deaths or life threatening complications.

Delivered by a trained midwife or MD in any office, using a modified IUD inserter, a 252 mg dose of 7 tiny quinacrine pellets is placed at the fundus of the uterus. The pellets dissolve quickly. The fluid causes inflammation and then scarring at the opening of the fallopian tubes. This prevents further births.  With two treatments a month apart, studies show low failure rates with no evidence of cancer. As the drug is off-patent, the cost of the pellets and inserter is under $5.  Surgical sterilizations often cost well over $2000 in the United States.

As with every method of contraception developed so far, tests have been conducted in many countries.  The famous birth control Pill had many such test sites.  QS has now been used in some cases for over 20 years and in 25 countries, producing a shelf of sound scientific studies demonstrating a safety record superior to surgical sterilization.  But its opponents are implacable, often resorting to devious measures to undermine confidence in the method.

A scientifically unsupported WHO letter claimed “WHO and FDA officials would be surprised if quinacrine doesn’t turn out to be carcinogenic.”  This letter induced the Vietnamese government to stop its successful program in late 1993. Quinacrine has been used for 60 years by over 100 million people for several purposes with no cancer clusters. Without this choice, the Vietnamese government has estimated that more than 40,000 pregnancy related deaths will result. No science against QS has been offered.

QS was banned in India and Chile following a front page Wall Street Journal article that badly bent the facts. Fortunately, CBS’s 60 Minutes presented a favorable segment in late 1998.  The vast disinformation campaign by uninformed feminists and traditional family planning opponents has now been fully discredited by sound scientific investigations and a long favorable experience with QS in Chile.

After almost a year of intensive study, the National Medical Committee (NMC) of Planned Parenthood Federation of America (PPFA) recommended that PPFA obtain FDA approval for a Phase II/III clinical trial in the US and invite other countries to join.  However, PPFA’s board decided to await results of a neonatal mouse study that may be completed by the end of 2001.

With QS there are no reported deaths and no life threatening incidents in over 100,000 cases.  Quinacrine has been around for over 60 years and widely used for malaria, lupus, tapeworm, and giardia by over 100 million people worldwide. There are at least 150 million women of childbearing age who wish to never have another baby, but who lack access to the means of halting further pregnancies. And any government approving QS will need NO foreign aid for sterilization services, as QS can be provided so economically. Whoever hears of QS always asks why it is not available NOW.  It is indeed a cogent question, which women need to ask in loud voices.  QS, the most important advance in contraception since the Pill, is a vital new choice. To learn more, try the web site (www.quinacrine.com) and demand answers! Here are three physicians to present their own conclusions:  Jack Lippes, School of Medicine, State University of New York at Buffalo, Dr. Krishna Jaffa had been responsible for clinical trials in her country and Mildred A. Hanson, former Medical Director of Planned Parenthood of Minnesota.